| K252350 — da Vinci SP Firefly Imaging System | Intuitive Surgical, Inc. Aug 28, 2025 |
| K252437 — JAZZ Spinal System | Implanet Aug 28, 2025 |
| K250788 — Definium Tempo Select | Ge Hualun Medical Systems Co. , Ltd. Aug 28, 2025 |
| K243901 — SmartPilot YpsoMate NS-A2.25 | Ypsomed AG Aug 28, 2025 |
| K252411 — JARVIS Glenoid Reverse Shoulder Prosthesis | FH Industrie Aug 28, 2025 |
| K252505 — Powder-Free Vinyl Exam Gloves, clear | Basic Medical Technology, Inc. Aug 28, 2025 |
| K252057 — Symphony Thrombectomy System and Symphony 16F 82cm Thrombectomy System | Imperative Care, Inc. Aug 28, 2025 |
| K252383 — Somfit D | Compumedics Limited Aug 28, 2025 |
| K252118 — CLUNGENE Multi-Drug Test Easy Cup; CLUNGENE Multi-Drug Home Test Easy Cup | Hangzhou Clongene Biotech Co., Ltd. Aug 27, 2025 |
| K250947 — VistaSoft 4.0 and VisionX 4.0 | Durr Dental SE Aug 27, 2025 |
| K243166 — Dermalage | Infection Elimination Solutions, LLC Aug 27, 2025 |
| K251716 — Nitrile Powder-Free Exam Gloves Tested for Use with Chemotherapy Drugs, Opioid Fentanyl Citrate, Simulated Gastric Acid and Xylazine in Fentanyl Citrate | Basic Medical Technology, Inc. Aug 27, 2025 |
| K241766 — QMAPP® (Hemo, Hemo Lite, PCM, GO, Hybrid) | Fysicon BV Aug 27, 2025 |
| K243774 — ELID (Endoscopic Less Invasive Decompression) System | Lesspine Innovations Aug 27, 2025 |
| K251382 — Phoenix Sinus Tarsi Stent System | Astra Orthomed, Inc. Aug 27, 2025 |
| K251415 — Additively Manufactured Aligner Resin | Aidite (Qinhuangdao) Technology Co., Ltd. Aug 27, 2025 |
| K252419 — HOTWIRE RF GUIDEWIRE (901XXX); HOTWIRE RF GUIDEWIRE (902XXX) | Atraverse Medical, Inc. Aug 27, 2025 |
| K250080 — QIAstat-Dx Respiratory Panel Plus; QIAstat-Dx Respiratory Panel Mini | QIAGEN GmbH Aug 27, 2025 |
| K243687 — Vital Signs | Oxehealth Limited Aug 27, 2025 |
| K251068 — KnoxFog Anti-fogging Device | Uv One Hygienics, Inc. Aug 27, 2025 |
| K251752 — Flexible Bronchoscope (BS27U-12EU, BS27U-12US, BS38U-20EU, BS38U-20US) | Shanghai AnQing Medical Instrument Co., Ltd. Aug 27, 2025 |
| K241882 — Fetal & Maternal Monitor (F15A, F15A Air) | Edan Instruments, Inc. Aug 27, 2025 |
| K250625 — Portable oxygen concentrator (W-R1(MAX)); Portable oxygen concentrator (W-R1); Portable oxygen concentrator (W-R2); Portable oxygen concentrator (W-R2(Lite)) | Nanjing Yinuoji Medical Technology Co., Ltd. Aug 27, 2025 |
| K251637 — Dewin Reproductive Media (Dewin Gamete Buffer [with HSA and without HSA]; Dewin Follicle Flushing Solution, Dewin One Step medium [with HSA and without HSA]) | Donnevie Medical Technology (Shanghai) Co. , Ltd. Aug 27, 2025 |
| K252526 — Rapid DeltaFuse | Ischemaview, Inc. Aug 26, 2025 |
| K244061 — X-Wire Guidewire | Imperative Care, Inc. Aug 26, 2025 |
| K250049 — Medical Video Endoscope [Standard Deflection] (URS3005); Medical Video Endoscope [Reverse Deflection] (URS3005E); Medical Video Endoscope [Standard Deflection] (URS3006); Medical Video Endoscope [Reverse Deflection] (URS3006E); Medical Video Endoscope [Standard Deflection] (URS3016); Medical Video Endoscope [Reverse Deflection] (URS3016E); Image processor (DIS8000) | Seplou (Zhuhai) Co., Ltd. Aug 26, 2025 |
| K250261 — Heager Medical Laser Family (Sabrina/Adolf) | Heager GmbH Aug 26, 2025 |
| K251983 — Brainomix 360 Triage Stroke | Brainomix Limited Aug 26, 2025 |
| K251305 — Ultra-Fast Vitri; Ultra-Fast Warm | Kitazato Corporation Aug 26, 2025 |
| K243834 — NobelZygoma TiUltra Implant system | Nobel Biocare AB Aug 25, 2025 |
| K251811 — Motor and Apex Module (MaAM) | Dentsply Sirona, Inc. Aug 25, 2025 |
| K251440 — CRYOcheck Chromogenic Factor VIII | Precision Biologic, Inc. Aug 25, 2025 |
| K251593 — DenMat Multilayered Zirconia Disc | Denmat Holding, LLC Aug 25, 2025 |
| K251246 — Sparrow Ascent | Spark Biomedical, Inc. Aug 25, 2025 |
| K243709 — NeuroEars-Anna | Neuroears, Inc. Aug 25, 2025 |
| K243800 — PRO Pen Microneedling System (6883) | Dermalogica, LLC Aug 25, 2025 |
| K243634 — Maxx Libertas Bipolar Hip Head (Bipolar Hip) | Maxx Orthopedics, Inc. Aug 25, 2025 |
| K243680 — Neurovascular Insight V1.0 | Olea Medical S.A.S. Aug 25, 2025 |
| K251404 — Quantra QStat Cartridge | Hemosonics, LLC Aug 25, 2025 |
| K252362 — GBrain MRI | Galileo Cds, Inc. Aug 22, 2025 |
| K250147 — CPS Locator 3D Delivery Catheter | Centerpoint Systems Aug 22, 2025 |
| K251277 — CoraForce Microcatheter, CoraFlex Microcatheter | Reflow Medical, Inc. Aug 22, 2025 |
| K251828 — CEREGLIDE 71 Catheter System; Cerenovus Aspiration Tubing Set | Cerenovus, Inc. Aug 22, 2025 |
| K251604 — CareSuperb COVID-19/Flu A&B Antigen Combo Home Test | Access Bio, Inc. Aug 22, 2025 |
| K243660 — Monoject 1mL Tuberculin Syringe Luer-Lock Tip (1180100777); Monoject 3mL Syringe, Luer-Lock Tip (1180300777); Monoject 6mL Syringe, Luer-Lock Tip (1180600777); Monoject 12mL Syringe, Luer-Lock Tip (1181200777); Monoject 20mL Syringe, Luer-Lock Tip (1182000777); Monoject 35mL Syringe, Luer-Lock Tip (1183500777); Monoject 60mL Syringe, Luer-Lock Tip (1186000777); Monoject 3mL Syringe, Luer-Lock Tip (8881513934); Monoject 6mL Syringe , Luer-Lock Tip (8881516937); Monojec | Cardinalhealth Aug 22, 2025 |
| K251884 — One-Fil Putty Injectable | Mediclus Co., Ltd. Aug 22, 2025 |
| K252303 — Stem Extension Line (USTAR II System) | United Orthopedic Corporation Aug 22, 2025 |
| K252302 — CARTO 3 EP Navigation System V8.1 | Biosense Webster, Inc. Aug 22, 2025 |
| K251192 — Diagnostic Ultrasound System (MX7); Diagnostic Ultrasound System (MX7T); Diagnostic Ultrasound System (Vaus7); Diagnostic Ultrasound System (Zeus); Diagnostic Ultrasound System (ME7); Diagnostic Ultrasound System (Anesus ME7); Diagnostic Ultrasound System (Anesus ME7T); Diagnostic Ultrasound System (MX7P); Diagnostic Ultrasound System (MX7W); Diagnostic Ultrasound System (MX8); Diagnostic Ultrasound System (MX8T); Diagnostic Ultrasound System (Vaus8); Diagnostic Ultrasound System (ME8) | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. Aug 22, 2025 |